Phase 2 N=35 Randomized Triple-blind Treatment

Valganciclovir Therapy in Infants and Children With Congenital CMV Infection and Hearing Loss

Cytomegalovirus Infection

Bottom Line

View on ClinicalTrials.gov: NCT01649869 ↗

Enrolled (actual)

Serious AEs

2.9%

Results posted

Jun 2021

Primary outcome: Primary: Number of Ears That Had (1) Improved Hearing or no Change in Hearing (2) Worsened Hearing. — 27; 20; 1; 6 Ears — p=0.0859

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Placebo (Other); Valganciclovir (Drug)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Primary completion: Dec 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Ears That Had (1) Improved Hearing or no Change in Hearing (2) Worsened Hearing.	27; 20; 1; 6	0.0859
SECONDARY Number of Best Ear That Had (1) Improved Hearing or no Change in Hearing (2) Worsened Hearing [ex. Improved+ no Change (Normal to Normal) Versus Other].	9; 6; 6; 6	0.7068
SECONDARY Change in Best Ear Hearing Assessments [Improved Versus Other] Between Baseline and Study Month 6.	0; 0; 15; 12	1
SECONDARY Change in Best Ear Hearing Assessments [Worse + no Change (Abnormal to Abnormal) Versus Other] Between Baseline and Study Month 6.	6; 6; 9; 6	0.7068
SECONDARY Change in Best Ear Hearing Assessments [Worse Versus Other] Between Baseline and Study Month 6.	0; 3; 15; 9	0.0752
SECONDARY Change in Total Ear Hearing Assessments [Improved Versus Other] Between Baseline and Study Month 6.	0; 0; 28; 26	—
SECONDARY Change in Total Ear Hearing Assessments [Worse+ no Change (Abnormal to Abnormal) Versus Other] Between Baseline and Study Month 6.	19; 20; 9; 6	0.4823
SECONDARY Change in Total Ear Hearing Assessments [Worse Versus Other] Between Baseline and Study Month 6.	1; 6; 27; 20	0.0859
SECONDARY Association of Change in Viral Load (Blood) With Change in Total Ear Hearing at 6 Months	1.396; 1.326	0.8212
SECONDARY Association of Change in Viral Load (Saliva) With Change in Total Ear Hearing at 6 Months	2.447; 2.290	0.8356
SECONDARY Association of Change in Viral Load (Urine) With Change in Total Ear Hearing at 6 Months	3.562; 3.583	0.7961
SECONDARY Association of Change in Viral Load (Blood) With Change in Best Ear Hearing at 6 Months	1.396; 1.359	0.8675
SECONDARY Association of Change in Viral Load (Saliva) With Change in Best Ear Hearing at 6 Months	2.447; 2.423	0.9682
SECONDARY Association of Change in Viral Load (Urine) With Change in Best Ear Hearing at 6 Months	3.562; 3.831	0.6063
SECONDARY Detection of Viruria (Urine) by PCR Six Weeks After Trial Entry	11; 1; 1; 11	0.0001 sig
SECONDARY Detection of Viruria (Urine) by PCR Six Month After Trial Entry	10; 11; 1; 3	0.6043
SECONDARY Detection of Viremia (Blood) by PCR Six Weeks After Trial Entry	4; 2; 11; 12	0.6513
SECONDARY Detection of Viremia (Blood) by PCR Six Month After Trial Entry	4; 3; 11; 12	1.0
SECONDARY Detection of CMV in Saliva by PCR Six Weeks After Trial Entry	9; 3; 7; 13	0.0659
SECONDARY Detection of CMV in Saliva PCR Six Month After Trial Entry	8; 7; 8; 9	1.0
SECONDARY The Quantitative Log Change in Viremia From Baseline to Month 6.	0.4908; -0.1528	—
SECONDARY The Quantitative Log Reduction in Viruria Detected After 6 Weeks of Therapy	1.2152; 0.8390	—
SECONDARY The Quantitative Log Reduction in CMV in Saliva Detected After 6 Weeks of Therapy	1.3202; 0.0057	—
SECONDARY Number of Adverse Events in the Active Group That Resulted in Discontinuation of Valganciclovir	17; 0	—
SECONDARY Adverse Event (AE) Resulting in Unresolved Outcome	18; 17; 0; 0	—
SECONDARY Adverse Event (AE) Resulting in Unanticipated Medically Attended Visit	15; 17; 3; 0	—

Summary

This is an international, multi-center, double-blind, placebo-controlled evaluation valganciclovir treatment for up to 54 children (up to 4 years of age) with virologically-confirmed congenital CMV infection and hearing loss. Subject participation will be over a six-month period and study subjects will be stratified according to age. The primary objective is to assess whether a six-week course of oral valganciclovir can stabilize the hearing of children with congenital CMV infection who present with hearing loss.

Eligibility Criteria

Inclusion Criteria

Signed informed consent from parent(s) or legal guardian(s)
Sensorineural hearing loss (>/= 21dB in one or both ears, documented within 12 weeks prior to study entry)
Children from 1 month through 3 years of age (up to the 4th birthday)

Exclusion Criteria

Imminent demise
Profound sensorineural hearing loss (> 90dB) in both ears
Patients receiving other antiviral agents or immune globulin
Gastrointestinal abnormality which might preclude absorption of an oral medication (e.g., a history of necrotizing enterocolitis)
Documented renal insufficiency, as noted by a creatinine clearance < 10 mL/min/1.73m2 at time of study enrollment
Breastfeeding from mother who is receiving ganciclovir, valganciclovir, foscarnet, cidofovir, or maribavir
Infants known to be born to women who are HIV positive (but HIV testing is not required for study entry).
Current receipt of other investigational drugs
Previous receipt of ganciclovir or valganciclovir
Known hypersensitivity to ganciclovir, valganciclovir, or components of the product
Inability to attend follow-up hearing and clinical assessments
Infants with Auditory neuropathy/dyssynchrony.
Children with another known etiology for SNHL (e.g. connexin 26, syndrome or metabolic disorder associated with SNHL, inner ear malformation and widened vestibular aqueducts, meningitis).

Exclusion of each of these conditions is not required for trial enrollment.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01649869). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.